Oncentra Prostate is a software application intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources The software should only be used by a person trained in brachytherapy techniques (such a person will be referred to as the user).

Device Description

Oncentra Prostate is a "real time" treatment planning system for brachytherapy, specially designed for the treatment of prostate cancer. Direct 3D ultrasound imaging of the implant gives the possibility to update the treatment plan during insertion of the catheters in the prostate. Before treatment, the software provides the physician with anatomical and dosimetric information, which is used to determine the positioning and loading of radioactive sources. The software also provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution (e.g. dose verification at a point and dose volume histograms).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Oncentra Prostate 4.0 device, based on the provided text:

Key Takeaways Before Diving In:

No Clinical Study: The most crucial point is that "Clinical testing was not required to demonstrate substantial equivalence." This means there was no clinical study conducted to establish acceptance criteria or prove device performance in a real-world clinical setting.
Focus on Non-Clinical Verification: The submission relies entirely on non-clinical testing and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) from a clinical study are provided, this table will reflect the general statements made in the document regarding non-clinical performance.

Acceptance Criteria Category (Implied)	Stated Device Performance
Safety and Effectiveness	"Oncentra Prostate 4.0 functions conform its specifications, is safe and effective for its intended use..."
Performance vs. Predicate Device	"...and performs as well as or better than its predicate devices."
Hazard Analysis	"All relevant hazards were analyzed and appropriate measures were verified."
Dose Calculation Accuracy	"Dose calculation was validated against reference standards in the same way as dose calculations of the predicate devices were validated."
Functionality	"Oncentra Prostate 4.0 functions conform its specifications..."
Substantial Equivalence	Demonstrated through comparison to predicate devices (Swift 2.0 and Spot Pro).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set was used for performance evaluation.
Data Provenance: Not applicable. No clinical data was used for performance evaluation. The "non-clinical testing" likely involved internal engineering tests, software validation, and comparison to theoretical models or existing data sets from predicate devices, but details are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. No clinical test set with expert-established ground truth was used.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No. The document explicitly states, "Clinical testing was not required to demonstrate substantial equivalence." The device is a treatment planning system, not an AI diagnostic tool designed to assist human readers in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the context of typical AI performance studies. While the software has standalone functions (e.g., dose calculation, auto-contouring), the document doesn't provide specific standalone performance metrics (e.g., accuracy of auto-contouring compared to ground truth) or a study design for evaluating this. It states that "non-clinical testing" and "verification and validation was performed according Nucletron’s procedures" and that "Dose calculation was validated against reference standards." These are internal quality and verification checks, not formal standalone performance studies in a regulatory sense that would typically involve a human-generated ground truth and associated metrics.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical testing mentioned:
- Reference Standards: For dose calculation validation. The exact nature of these standards (e.g., phantom measurements, theoretical models, established physics data) is not detailed.
- Specifications: The device's functions were tested against its own design specifications.
- Predicate Device Performance: The device's overall performance was benchmarked against existing legally marketed devices (Swift 2.0 and Spot Pro), implying that their established performance serves as an indirect "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The document does not describe the device as a machine learning or AI model that requires a "training set" in the conventional sense. It's a software application for brachytherapy treatment planning. If it uses any internal algorithms that were "trained," this information is not disclosed.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set was Established: Not applicable, as there's no mention of a traditional training set for a machine learning model.

Summary

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NOV 1 8 20

August 20

Image /page/0/Picture/3 description: The image shows the Nucletron logo. The logo consists of a black circle with two white circles on the left side, followed by the word "Nucletron" in black bold letters. Below the word "Nucletron", there is the phrase "Improving patient care" in a smaller, cursive font.

Nucletron Corporation 7021 Columbia Gateway Drive Suite 200 Columbia, MD 21046-2133 U.S.A. 410-312-4100 Phone Fax 443-769-1570

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92

Submitter of 510(k):

Company name: Registration number: Address:

Phone: Fax: Correspondent:

Nucletron Corporation 1121753 7021 Columbia Gateway Drive Columbia, MD 21046-2133 410-312-4100 443-7697546 Michael Paul, Quality Assurance & Regulatory Affairs Manager August 10, 2011

Date:

New Device Name:

Trade/Proprietary Name:	Oncentra Prostate 4.0
Common/Usual Name:	Treatment Planning System for Radiation Therapy
Classification Name:	System,Planning,Radiation Therapy Treatment
Classification:	21Cfr892.5050 Class II

Legally Marketed Device(s)

Our modified device is based on the legally marketed device cited in the table below:

Manufacture	--------1846 15 2012 2012 2017 2014.1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device11 40	510/7
Nucietron BV	Shotﺎ ﺍﻟﻤﺴﺎ	- דרימח/ י
Nucletron BV------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1	" Swift " "	K031158

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Device description:

The features of the Oncentra Prostate software depend on the installed modules, as shown in the following table:

Module	Key Features
Oncentra Prostate -Basic Module	Full screen user interface Template calibration and alignment Manual VOI definition Manual and automatic catheter placement, taking into account VOIs Manual catheter reconstruction Auto-activation of dwell positions within VOI Manual (de)activation of dwell positions Manual editing of dwell weights and times Optimization techniques: geometric optimization, optimization on dose points Optimization history for evaluation Evaluation tools: cumulative DVH, differential DVH Multiple graphical tools Configuration customization file Output: printer, afterloader system, preview plot
Oncentra Prostate -SmoothBase	Patient administration User management
Oncentra Prostate -3D Ultrasound	3D ultrasound acquisitions together with stepper encoder positioning system Selectable frame to frame step size Stepper encoder controlled volume navigation 3D isodose surface Resize volume of interest
Oncentra Prostate -Auto recognition ofcatheters	Automatic catheter recognition on US image (requires 3D ultrasound)
Oncentra Prostate -Auto contouring	Automatic VOI contouring based on 3 slices contours Automatic VOI contouring based on base contours and a 3D path Automatic 2D VOI contouring based on US image detection
Oncentra Prostate -Inverse Planning	Multi-objective anatomy-based optimization Multi-objective DVH-based optimization Decision tools

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Traditional 510(k) Nucletron Oncentra Prostate 4.0

Module	Key Features
Oncentra Prostate –RT-HDR WilliamBeaumont	• Anatomic placement of catheters using customizable parametersaccording to the William Beaumont Hospital method
Oncentra Prostate –CT/MR and advancedoptimizations	• Planning on CT and MR modality• Import of VOIs and plans of different modalities• Hybrid catheter reconstruction on CT• Volume evaluation• Temporary availability of up to 10 volumes of different modalities• 3D display of surface and volume with clipping• DVH shaper• Plan comparison (multiple plans)• HIPO inverse planning
Oncentra Prostate –Color US (Doppler)	• Support of color US imaging for acquisition and planning
Oncentra Prostate –Fusion for all modalities	• Volume fusion and registration of two volumes

Intended use:

Oncentra Prostate is a software application for brachytherapy treatment planning, for the treatment of cancer (i.e. intercavitary, interstitial, intraluminal) involving radioactive sources.

Comparison with predicative devices

Oncentra Prostate 4.0 has the same intended use and the same scientific technology as its predecessor Swift 2.0 (K031158). Planning functionality for seeds is added and uses the same scientific technology as the predicate device Spot Pro (K022741).

Summary of Non- clinical testing

All relevant hazards were analyzed and appropriate measures were verified. Verification and validation was performed according Nudetron's procedures.

Dose calculation was validated against reference standards in the same way as dose calculations of the predicate devices were validated.

Oncentra Prostate 4.0 functions conform its specifications, is safe and effective for its intended use and performs as well as or better than its predicate devices.

Summary of Clinical testing

Clinical testing was not required to demopstrate substantial equivalence.

Name: John Lapre

Aug. 12 2011
Date

Name: John Lapre
Title: Vice President Research & Development
Nucletron B.V.
Veendaal, The Netherlands

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

NOV 1 8 2011

Mr. Michael Paul Regulatory Affairs/Quality Assurance Manager Nucletron Corporation 7021 Columbia Gateway Drive. Suite 200 COLUMBIA MD 21046-2133

Re: K112420

Trade/Device Name: Oncentra Prostate 4.0 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 20, 2011 Received: August 23, 2011

Dear Mr. Paul:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number <112420

Device Name

Oncentra Prostate 4.0

Indications for Use

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D)

510K

AND/OR

Over-The-Counter Use (Part 21 CFR 801 subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.